The Evolution of Regulating the OTC pricing in Bulgaria
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15 Aug The Evolution of Regulating the OTC pricing in Bulgaria

Posted at 14:00h in Pricing & Reimbursement by

After the amendments to the Bulgarian regulation on pricing and reimbursement in December 2014, it became increasingly difficult to determine whether the government is regulating or merely registering OTC prices in Bulgaria.

Under the Bulgarian Law on Medicinal Products in Human Medicine (the Drug Law), the competent authority—the National Council on Pricing and Reimbursement—regulates the prices of prescription-only medicines (Rx). For over-the-counter medicinal products (OTCs), however, the Drug Law provides for price registration rather than price regulation. Marketing authorisation holders (MAHs) are free to set and register the maximal sales price of their OTC products, and no EU reference pricing system applies. The registration of a maximal sales price serves as a ceiling to prevent speculative increases within the supply chain but is not intended to control the pricing policy of MAHs. From this perspective, OTCs represent a “free-pricing” segment of the market, in contrast to Rx medicines, for which MAHs must declare the lowest ex-factory price among 10 reference countries (EU Member States).

In April 2013, the government introduced a transitional rule in the pricing regulation limiting MAHs: the registered maximal sales price of an OTC could not be increased by more than the relevant inflation percentage from the date of its last price registration. Initially valid for one year, this measure was extended in August 2014 to the end of that year, and then in December 2014 through the end of 2015. Further extensions followed—first to the end of 2017, then to the end of 2019. Given that the Bulgarian National Statistical Institute reported deflation during much of that period, the measure effectively operated as a price freeze on OTC products.

In 2020, this rule was incorporated permanently into the pricing framework, ceasing to be transitional.

Five years later, in August 2025, the government moved to close even the remaining loopholes in the applicable legislation. Until now, some MAHs attempted to circumvent the inflation-linked cap by deregistering their OTC medicinal products, intending to re-register them later at a higher price—accepting the commercial risk of withdrawing the product from the market for a certain period. The new rule, however, removes this option: if a product’s maximal sales price has been deregistered within the past year, any subsequent registration for the same product must be based on the previously registered price, adjusted only by the official inflation index. Where such pricing is commercially unfeasible, MAHs are left with two choices—develop more sophisticated pricing strategies or withdraw from the market for at least one year. The latter is, of course, the worst-case scenario from the patients’ perspective.

OTCs are not reimbursed from public funds, and their use is entirely patient-financed. Nevertheless, the government has, over the years, persistently tied any OTC price increases to the officially reported inflation rates—an approach that is legally debatable but socially motivated. In response, many MAHs have already “front-loaded” their registered prices at the time of market entry, thereby undermining the original objective of preventing excessive mark-ups further along the supply chain.

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Last update: August 2025.